In the last couple of years, several new biobanks have been established to enable the study of health developments of people and their families over their entire lifetime. This paper reviews the legal and ethical implications of a loss of decision-making capacity by research subjects in long-term research associated with large biobanks.

Typically anorexia nervosa is diagnosed as a condition of teenage girls where the rates of mortality and morbidity are very high and recovery rates very low. This chapter discusses the condition as experienced in Australia by older women who have either lived with anorexia during adolescence and as young women or who have been diagnosed later in life. The discussion traverses issues of consent to treatment or its refusal, capacity to provide consent, and the application of human right protections arising from various human rights instruments.

This article critically evaluates the Medicines and Healthcare products Regulatory Agency’s announcement, in March 2008, that GlaxoSmithKline would not face prosecution for deliberately withholding trial data, which revealed not only that Seroxat was ineffective at treating childhood depression but also that it increased the risk of suicidal behaviour in this patient group. The decision not to prosecute followed a four and a half year investigation and was taken on the grounds that the law at the relevant time was insufficiently clear. This article assesses the existence of significant gaps in the duty of candour which had been assumed to exist between drugs companies and the regulator, and reflects upon what this episode tells us about the robustness, or otherwise, of the UK’s regulation of medicines.

The notion of "consent" is frequently referred to as "informed consent" to emphasise the informational component of a valid consent. This article considers aspects of that informational component. One misuse of the language of informed consent is highlighted. Attention is then directed to some features of the situation in which consent would not have been offered had certain information been disclosed. It is argued that whether or not such consent is treated as sufficiently informed must, from a moral point of view, take account of four conditions. When these are applied to the operation of consent in relation to criminal responsibility for HIV transmission, the approach in some recent cases is shown to be morally questionable.

GPs’ representatives voted overwhelmingly this week for a system in which patients opt in to any sharing of medical data with third parties—rather than one in which their consent is assumed unless they opt out, the system favoured by the Department of Health. Clinical confidentiality depends on GPs being the prime data holder of their patients’ medical records, said the BMA’s annual conference of local medical committee representatives in London. It also strongly opposed using implied consent as justification for releasing information on named patients.

Since 1991, sperm donors in the UK have had the legal right to withdraw consent for the use of their sperm in fertility treatment. This has the potential to adversely affect patients. It may mean that previous recipients of a donor’s sperm cannot have further children who are full biological siblings to an existing child, and that embryos created from the donor’s sperm and a patient’s eggs must be destroyed. We have informally investigated withdrawal of consent by sperm donors donating after 1 April 2005, when lifelong anonymity for gamete donors ended.

With a national shortage of organ donors, the dilemma faced by surgeons is whether a transplant with what are called "marginal" organs from donors who could be higher risk, such as the elderly or patients with a history of cancer or drug abuse, is better than leaving a patient on a waiting list where they could die before a suitable donor can be found. Figures disclosed to File on 4 reveal that in 1998 13% of donor organs were "marginal", 10 years later this percentage had doubled. Everyone in the transplant field who has talked to the programme agreed the quality of organs from deceased donors was declining, accepting this meant added risks connected to the hearts, lungs, livers and kidneys used for transplants. As one doctor put it, this is a calculated gamble. Arising out of this comes the issue of informed consent. Who should have the final say whether an organ from a dead donor should be used, the professional or the patient?